On February 18, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, developing transformative therapies for patients with cancer and autoimmune diseases, reported Memorial Sloan Kettering Cancer Center’s (MSK) notification to the U.S. Food and Drug Administration (FDA) of a fatal serious adverse event (SAE) associated with a patient treated in the ongoing Phase 1, MSK-conducted dose-escalation clinical study of autologous mesothelin CAR T, ATA2271 (Press release, Atara Biotherapeutics, FEB 18, 2022, View Source [SID1234608314]). MSK has voluntarily paused enrollment of new patients in the study on a temporary basis while additional information regarding the case is gathered and reviewed. The FDA has notified MSK of its agreement with this approach.
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ATA2271 is a next-generation, autologous chimeric antigen receptor (CAR) T-cell therapy targeting mesothelin currently under clinical investigation in patients with malignant pleural mesothelioma. The single case involved a patient with a history of multiple malignancies and other comorbidities undergoing treatment for advanced recurrent mesothelioma. MSK is in the process of further evaluating the occurrence, including the extent of the relationship of the event to ATA2271.
"The safety of every patient participating in studies we are funding or conducting is of the utmost priority for Atara," said Jakob Dupont, MD, Head of Global Research & Development at Atara. "Clinical evaluation of the case remains ongoing, and we are working closely with investigators at MSK, who are conducting the ATA2271 study under their IND, to establish the underlying causes of the event. We anticipate providing a further update in the coming weeks following further discussion and consultation with MSK."
The median survival of treated patients with malignant pleural mesothelioma is 9-17 months even with successful completion of a combination of chemotherapy, aggressive surgical resection, and radiation therapy. The first six patients enrolled in the two lowest dose cohorts received either 1×106 cells/kg (patients 1-3) or 3×106 cells/kg (patient 4-6) intrapleural ATA2271. Within these two cohorts, no dose limiting toxicities have been reported to date. The patient event being reported relates to the first patient in a third, higher-dose cohort (6×106 cells/kg).
The temporary pause in ATA2271 study enrollment does not impact the IND-enabling work currently underway to advance ATA3271, a separate, off-the-shelf, allogeneic CAR-T therapy targeting mesothelin using next-generation PD1DNR and 1XX CAR technologies for patients with advanced mesothelioma. ATA3271, ATA3219, tab-cel, and ATA188 all utilize Atara’s allogeneic EBV T-cell platform, the safety and tolerability of which has been validated by clinical studies and experience in approximately 400 patients in various disease areas with no observed cytokine release syndrome (CRS) to date.
MSK Disclosure: MSK has intellectual property rights and associated interests by virtue of licensing agreements between MSK and Atara.